Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
OECD TG 422: N-Butylpyridinium chloride, NOAEL = 150 mg/kg bw / day 
OECD TG 416: Aluminum sulfate, NOAEL = 8.06 mg Al/kg bw / day.
OECD TG 416: Aluminum ammonium sulfate, NOAEL = 5.35 mg Al / kg bw /day
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
40.6 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
In aqueous environment the test material hydrolizes in a fast manner and forms multiple degradation products, namely Butylpyridinium Chloride and Aluminumoxychlorides and subsequently Aluminumoxide and HCl. Therefore data for the soluble aluminum fraction (worst case) and Butylpyridinium Chloride have been taken into account for the evaluation of the potential toxicity to reproduction. The latter compound was studied in the GLP compliant OECD TG 422 study while for soluble aluminum salts data from OECD 416 studies from the public scientific literature have been summarized.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Short description of key information:
N-Butylpyridinium chloride: OECD TG 422 NOEL= 75 mg/kg bw /d
Aluminum ammonium sulfate: OECD TG 416, NOAEL=5 mg (Al) /kg bw /d
Aluminum sulfate: OECD TG 416, NOAEL = 8 mg (Al) /kg bw /d

Justification for selection of Effect on fertility via oral route:
A study of the target compound (1-Butylpyridinium-heptachlorodialuminate) for reproductive toxicity is technically not possible. However, in order to fill the data gap, information for the degradation products for this endpoint has been acquired for N-Butylpyridinium chloride (GLP, OECD TG 422, reliability 1). In addition, data for water soluble aluminium salts relevant for this endpoint from the published literature have been considered. For this selection the lowest NOAEL obtained from all these studies was considered. The NOAEL of this study is based on Aluminum; thus the conversion to the relevant dose level for the target compound, BPyrAl2Cl7, is obtained taking the molar masses into account: i.e.: NOAEL = 5 mg Al/kg bw (Molar mass = 27 g/mol); Molar Mass of BPyrAl2Cl7 / Molar Mass of Al / Molar Mass Al equivalents = 8,12; NOAEL (corrected) = 5 mg Al /kg bw *8.12 = 40.6 mg BPyrAl2Cl7 / kg bw.

Effects on developmental toxicity

Description of key information
For the reproductive toxicity of the target compound studies are technically not possible. However, relevant information is available for the main degradation products, namely N-Butylpyridinium chloride for the cationic part, and two different aluminum salts for the anionic part of the molecule. 
For 1-Butylpyridinium chloride a NOAEL of 150 mg/kg bw /day was obtained while for the aluminum salts lower values in the range of 5 – 8 mg Al/kg bw/day have been established.
Taking a conservative approach into account we have considered the lowest NOAEL obtained for aluminum ammonium sulfate (5.35 mg/kg bw/d) as point of departure for the DNEL derivation.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

For the reproductive toxicity of the target compound studies are technically not possible. However, relevant information is available for the main degradation products, namely 1-Butylpyridinium chloride for the cationic part, and two different aluminum salts for the anionic part of the molecule.

For N-Butylpyridinium chloride a NOAEL of 150 mg/kg bw /day was obtained while for the aluminum salts lower values in the range of 5 – 8 mg Al/kg bw/day have been established.

Taking a conservative approach into account we have considered the lowest NOAEL obtained for aluminum ammonium sulfate (5.35 mg/kg bw/d) as point of departure for the DNEL derivation.